Licensure of gemtuzumab ozogamicin for the treatment of selected patients 60 years of age or older with acute myeloid leukemia in first relapse

This paper discusses background information and the body of clinical data that has been accumulated to demonstrate the efficacy and safety of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals, Philadelphia, PA). Based on these data, gemtuzumab ozogamicin was approved by the United States Food a...

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Bibliographic Details
Published in:Investigational new drugs 2002-11, Vol.20 (4), p.395-406
Main Authors: BERGER, Mark S, LEOPOLD, Lance H, DOWELL, James A, KORTH-BRADLEY, Joan M, SHERMAN, Matthew L
Format: Article
Language:English
Subjects:
Age
Aged
Aminoglycosides
Anti-Bacterial Agents - adverse effects
Anti-Bacterial Agents - chemistry
Anti-Bacterial Agents - therapeutic use
Antibodies
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - chemistry
Antibodies, Monoclonal - therapeutic use
Antibodies, Monoclonal, Humanized
Antigens
Antineoplastic agents
Binding sites
Biological and medical sciences
Blood
Blood platelets
Bone marrow
Chemotherapy
Clinical Trials as Topic - statistics & numerical data
Combined treatments (chemotherapy of immunotherapy associated with an other treatment)
Cytotoxicity
Drug dosages
FDA approval
Humans
Leukemia
Leukemia, Myeloid, Acute - drug therapy
Leukemia, Myeloid, Acute - prevention & control
Licensure
Medical prognosis
Medical sciences
Middle Aged
Patients
Pharmacokinetics
Pharmacology. Drug treatments
Remission (Medicine)
Secondary Prevention
Survival Rate
United States
United States Food and Drug Administration - legislation & jurisprudence
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Summary:This paper discusses background information and the body of clinical data that has been accumulated to demonstrate the efficacy and safety of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals, Philadelphia, PA). Based on these data, gemtuzumab ozogamicin was approved by the United States Food and Drug Administration for the treatment of patients with CD33-positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The recommended dosage of gemtuzumab ozogamicin is 9 mg/m2, administered as a 2-hour intravenous infusion for a total of 2 doses with 14 days between doses.
ISSN:0167-6997
1573-0646
DOI:10.1023/A:1020658028082